Biotek
by Chetan Meditech Pvt. Ltd. 296 variants
Ref BAS-9121Model Measurable Arthroscopy and Orthopaedic Instruments
Active
CE MDR
Valid until
1 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042103cmplins003YB 18904210398607 | Date25 Apr 2025 | StatusActive |
Certificates
- 2024-MDR/QS-040 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- BIOTEK, Cannudrill, Flowertip, AI Reamer, Shuttleferry, Shuttleferry I, sHUTTLEFERRY II, Arthrovims OnLoc
- Model / Reference
- Measurable Arthroscopy and Orthopaedic Instruments, BAS-9121
- Primary DI / UDI-DI
- 18904210398607
- Basic UDI-DI
- 89042103cmplins003YB
- EMDN Code
- L0299 Suture instruments, reusable - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000013541
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Chetan Meditech Pvt. Ltd.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No